Pre and post vitrectomy infliximab in Bechet's disease posterior uveitis

The effectiveness of pre and post operative infliximab in controlling Bechet's disease posterior uveitis in patients undergoing vitrectomy: a preliminary study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN20489230

Enrollment

Registered

2017-02-27

Start date

2014-02-01

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bechet's disease posterior uveitis Eye Diseases

Interventions

The drug infliximab was given in a dose of 5 mg/kg intravenous infusion over a three-hour period once every two weeks for 3 treatment sessions prior to the planned pars plana vitrectomy, after stoppag

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Bechet's disease persistent posterior uveitis not responding to systemic treatment 2. Eyes with dense persistent vitreous opacities 3. Eyes with epiretinal membranes 4. Persistent macular edema 5. Age 18-60 years

Exclusion criteria

Exclusion criteria: 1. Patients with active infections 2. End-stage disease 3. Impaired liver function, leucopenia and thrombocytopenia 4. Patients receiving immunosuppressants other than corticosteroids at time of application of the drug

Design outcomes

Primary

Measure	Time frame
The improvement of ocular inflammatory reaction in response to the drug used, monitored clinically (i.e. improvement in ocular pain, improvement of the visual acuity measured in Log MAR, improvement in anterior chamber flare and cells, improvement in vitreous cells), measured before the initiation of each new treatment cycle (every 2 weeks), as well as during the follow-up periods (monthly after stopping of the drug infliximab at the last session, for a 6-month period)	—

Measure

Time frame

The improvement of ocular inflammatory reaction in response to the drug used, monitored clinically (i.e. improvement in ocular pain, improvement of the visual acuity measured in Log MAR, improvement in anterior chamber flare and cells, improvement in vitreous cells), measured before the initiation of each new treatment cycle (every 2 weeks), as well as during the follow-up periods (monthly after stopping of the drug infliximab at the last session, for a 6-month period)

—

Secondary

Measure	Time frame
1. Reduction in concomitant corticosteroids requirements (average daily dose), as the doses are gradually tapered once improvement of ocular inflammatory reaction is achieved and continued reduction based on the patient’s response reaching the minimum daily dose sufficient to maintain quite eye with no active inflammatory reaction. 2. The occurrence of disease reactivation (relapses), where disease activity is defined as cells and flare in the anterior chamber, vitreous cells, retinal perivascular sheathing, retinal infiltration, new retinal hemorrhages or optic papillitis, monitored on a monthly basis after stopping of the drug infliximab for a total period of 6 months after the last treatment cycle	—

Measure

Time frame

1. Reduction in concomitant corticosteroids requirements (average daily dose), as the doses are gradually tapered once improvement of ocular inflammatory reaction is achieved and continued reduction based on the patient’s response reaching the minimum daily dose sufficient to maintain quite eye with no active inflammatory reaction. 2. The occurrence of disease reactivation (relapses), where disease activity is defined as cells and flare in the anterior chamber, vitreous cells, retinal perivascular sheathing, retinal infiltration, new retinal hemorrhages or optic papillitis, monitored on a monthly basis after stopping of the drug infliximab for a total period of 6 months after the last treatment cycle

—

Countries

Egypt

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026